Alendronate ( DrugBank: Alendronate )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病1
41巨細胞性動脈炎1
46悪性関節リウマチ5
50皮膚筋炎/多発性筋炎1
271強直性脊椎炎1
274骨形成不全症3
299嚢胞性線維症3

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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gender
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size
PhaseCountries
1NCT00004488
(ClinicalTrials.gov)
October 199818/10/1999Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's DiseaseGaucher's Disease;OsteopeniaDrug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferolChildren's Hospital Medical Center, CincinnatiNULLCompleted18 Years50 YearsBoth82Phase 2United States;Israel

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00138983
(ClinicalTrials.gov)
May 200029/8/2005Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardCompleted18 Years90 YearsBoth200Phase 3Netherlands

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02944799
(ClinicalTrials.gov)
December 201527/6/2016Alendronate Treatment of Osteoporosis in Rheumatoid ArthritisAlendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone MassRheumatoid Arthritis;OsteoporosisDrug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin DUniversity of AarhusNULLActive, not recruiting18 YearsN/AAll69Phase 2Denmark
2EUCTR2015-003638-28-DK
(EUCTR)
30/09/201528/08/2015Treatment of osteoporosis in patients with rheumatoid arthritis.ALOSTRAAlendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA Rheumatoid arthritis and osteoporosis
MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Alendronat Teva
INN or Proposed INN: Alendronic Acid
Other descriptive name: ALENDRONIC ACID
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Denmark
3NCT01770106
(ClinicalTrials.gov)
December 20123/1/2013RA Denosumab on Bone Microstructure StudyComparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled TrialRheumatoid ArthritisDrug: Denosumab;Drug: AlendronateChinese University of Hong KongNULLCompleted18 Years80 YearsFemale40Phase 4Hong Kong
4ChiCTR-TRC-09000473
2009-07-202009-07-15Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial.Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial. Rheumatoid ArthritisGroup B:MTX 7.5-20mg, orally taken once weekly for 48 week;Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks ;People's Hospital, Peking UniversityNULLCompleted18BothGroup B:160;Group A:160;China
5NCT00138983
(ClinicalTrials.gov)
May 200029/8/2005Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardCompleted18 Years90 YearsBoth200Phase 3Netherlands

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00138983
(ClinicalTrials.gov)
May 200029/8/2005Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardCompleted18 Years90 YearsBoth200Phase 3Netherlands

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01104987
(ClinicalTrials.gov)
October 200913/4/2010Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective TrialAnkylosing Spondylitis;OsteoporosisDrug: alendronateGöteborg UniversityNULLCompleted18 Years80 YearsBoth16Sweden

274. 骨形成不全症


臨床試験数 : 91 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000010615
2013/04/3030/04/2013Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form)Clinical study on efficacy of alendronate infusion for pediatric osteogenesis imperfecta (including severe form) - Alendronate infusion for osteogenesis imperfecta osteogenesis imperfectaEighteen micrograms (2 ml)/kg of alendronate will be infused in 1 hour every 4 weeks. The study duration is 6 months. When the patient's BMD reaches to the normal range for age, treatment with alendronate will be finished. When the patient's BMD does not reach to the normal range for age, alendronate will be continued for another 6 months.Tohoku University School of Medicine, Department of PediatricsNULLComplete: follow-up continuingNot applicable15years-oldMale and Female10Not applicableJapan
2NCT02303873
(ClinicalTrials.gov)
March 200719/11/2014Efficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis ImperfectaEfficacy and Safety of Alendronate in Chinese Children or Adolescents With Osteogenesis Imperfecta: an Age Stratified Prospective StudyOsteogenesis ImperfectaDrug: AlendronatePeking Union Medical College HospitalNational Natural Science Foundation of ChinaCompletedN/A18 YearsBoth99Phase 4NULL
3NCT00159419
(ClinicalTrials.gov)
August 19997/9/2005Bisphosphonate Therapy for Osteogenesis ImperfectaBisphosphonate Therapy for Osteogenesis ImperfectaOsteogenesis Imperfecta;Osteoporosis;Paget Disease of BoneDrug: Alendronate;Drug: PamidronateIndiana University School of MedicineNULLCompleted3 Years21 YearsAll18Phase 4United States

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00157690
(ClinicalTrials.gov)
December 20038/9/2005Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis PatientsA Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis PatientsCystic Fibrosis;Osteoporosis;Bone Diseases, MetabolicDrug: Alendronate;Drug: PlaceboMcMaster UniversityCentre hospitalier de l'Université de Montréal (CHUM);London Health Sciences Centre;University of Calgary;McGill University;Laval University;Merck Frosst Canada Ltd.Completed18 YearsN/ABoth56Phase 4Canada
2NCT01812551
(ClinicalTrials.gov)
October 200214/3/2013Treatment of Low Bone Density in Cystic Fibrosis.Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial.Osteoporosis;Cystic FibrosisDrug: Alendronate;Drug: PlaceboIstituto Auxologico ItalianoFondazione TelethonCompleted5 Years30 YearsBoth171Phase 3Holy See (Vatican City State);Italy
3NCT00004489
(ClinicalTrials.gov)
October 199818/10/1999Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related OsteoporosisOsteoporosis;Cystic FibrosisDrug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferolUniversity of North CarolinaNULLCompleted18 Years45 YearsBoth60N/AUnited States